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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

MIRALAX: 1,357 Adverse Event Reports & Safety Profile

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1,357
Total FAERS Reports
9 (0.7%)
Deaths Reported
26
Hospitalizations
1,357
As Primary/Secondary Suspect
6
Life-Threatening
8
Disabilities

First Report: 2004 · Latest Report: 20140611

What Are the Most Common MIRALAX Side Effects?

#1 Most Reported
Drug ineffective
341 reports (25.1%)
#2 Most Reported
Off label use
294 reports (21.7%)
#3 Most Reported
Incorrect drug administration duration
283 reports (20.9%)

All MIRALAX Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug ineffective 341 25.1% 0 2
Off label use 294 21.7% 0 5
Incorrect drug administration duration 283 20.9% 0 5
Inappropriate schedule of drug administration 172 12.7% 0 1
Drug administered to patient of inappropriate age 116 8.6% 0 0
Overdose 102 7.5% 1 4
Diarrhoea 99 7.3% 1 5
Drug effect decreased 89 6.6% 0 0
Underdose 80 5.9% 0 1
Product quality issue 74 5.5% 0 1
Drug prescribing error 72 5.3% 0 0
Product taste abnormal 52 3.8% 0 0
Product odour abnormal 40 3.0% 0 0
Flatulence 39 2.9% 1 3
Nausea 35 2.6% 1 2
Drug effect delayed 33 2.4% 0 0
Abdominal pain upper 32 2.4% 0 0
Abdominal distension 31 2.3% 2 2
Expired product administered 30 2.2% 0 0
Abnormal faeces 28 2.1% 0 1

Who Reports MIRALAX Side Effects? Age & Gender Data

Average age: 50.5 years. Most reports from: US. View detailed demographics →

Is MIRALAX Getting Safer? Reports by Year

YearReportsDeathsHosp.
2004 2 1 0
2005 1 0 1
2007 2 0 0
2008 4 0 0
2009 7 0 0
2010 6 0 0
2011 6 0 1
2012 22 0 1
2013 163 2 5
2014 322 0 5

View full timeline →

What Is MIRALAX Used For?

IndicationReports
Product used for unknown indication 794
Constipation 419
Bowel preparation 22
Colonoscopy 22
Irritable bowel syndrome 22
Bowel movement irregularity 16
Faeces hard 11
Constipation prophylaxis 8
Medical observation 8
Abnormal faeces 5

MIRALAX vs Alternatives: Which Is Safer?

MIRALAX vs MIRCERA MIRALAX vs MIRENA MIRALAX vs MIRIKIZUMAB-MRKZ MIRALAX vs MIRTAZAPINE MIRALAX vs MIRVETUXIMAB SORAVTANSINE-GYNX MIRALAX vs MISOPROSTOL MIRALAX vs MITAPIVAT MIRALAX vs MITOMYCIN MIRALAX vs MITOTANE MIRALAX vs MITOXANTRONE

Official FDA Label for MIRALAX

Official prescribing information from the FDA-approved drug label.